RWD SIG

Purpose

To increase collaboration and enhance awareness of strategies and methodologies applied in the utilization of Real World Data in the pharmaceutical industry.

Objectives

Our objectives include:

  • Facilitate sharing of case studies and experiences in this area
  • Collate and summarise publications, articles, presentations, training
  • Identify emerging news and trends
  • Organise and/or participate in workshops related to RWD
  • Collaborate with key stakeholder groups (EFSPI/PSI, EFPIA, ISPOR,  regulatory and academia)
  • Provide comments on RWD related guidelines, e.g. country-specific methods guidelines, FDA methods guidelines, ISPOR etc.
  • Develop/highlight best practices and recommendations
  • Influence industry practice and acceptance of approaches by regulators and other stakeholders

 

Let's T@lk Real Corner

This corner is created to discuss Real World Data (RWD) topics coming from industry, academia and Health Authorities.

Blog Posts:

Let's T@lk Real: Federated Data 9th December 2024

Let's T@lk Real: Immortal Time Bias and Time Zero 22 April 2024

Let's T@lk Real: DAGs 5th December 2023

Let's T@lk Real: What are RWD 3rd July 2023

Let's T@lk Real: External Controls 22nd May 2023

Let's T@lk Real: Survey 19th December 2022

 

Who we are

SIG MemberOrganisation
Antonio Remiro-AzocarNovo Nordisk
Deepak ParasharWarwick University
Eleanor RalphsIQVIA
Elizabeth MerrallJanssen
Fiona GrimsonUCB
Federica BelmonteNovo Nordisk
Helen BroadhurstPlus-Project
Jixian (Jason) WangBristol Myers Squibb
Josie Wolfram (Co-chair)Astellas
Laura DayAdaptimmune
Louise LinsellVisible Analytics Limited
Min-Hua JenEli Lilly
Orlando DoehringGSK
Rachel ThamAstellas
Rima Izem (Co-chair)Novartis
Thomas DebraySmart Data Analysis and Statistics B.V.
Victoria StraussBoehringer Ingelheim

 

We also have an observer/informed member list who are included on meeting invites and mails, but we don’t expect active contributions nor list you on the SIG page members list. Shifting status to active is then welcomed any time!

Call for members

If you are interesting in joining the RWD SIG or would like to change your PSI RWD SIG membership status, please use the sign up form.

Frequency of Meetings

Monthly teleconferences

 

Upcoming Events

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence

Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.

PSI Training Course: Pediatric Extrapolation

This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.

PSI Career Young Virtual Event (Q3 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Pre-Clinical SIG Webinar: AI agents for drug discovery and development

AI agents are large language models equipped with tools that can autonomously tackle challenging tasks. This talk will explore how generative AI agents can enable biomedical discovery.

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